TRISCEND II Pivotal Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,070

Participants

Timeline

Start Date

April 9, 2021

Primary Completion Date

December 21, 2025

Study Completion Date

June 27, 2030

Conditions
Tricuspid Valve RegurgitationTricuspid Valve InsufficiencyTricuspid Valve DiseaseHeart Valve DiseasesCardiovascular DiseasesHeart Failure
Interventions
DEVICE

Edwards EVOQUE System

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT

DRUG

Optimal Medical Therapy

Optimal Medical Therapy

Trial Locations (62)

10016

NYU Langone Health, New York

10021

Weill Cornell Medicine-New York Presbyterian Hospital, New York

10032

Columbia University Medical Center/NYPH, New York

10075

Lenox Hill Hospital, New York

10461

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital, Manhasset

11576

St. Francis Hospital, Roslyn

14203

State University of New York at Buffalo, Buffalo

19096

Lankenau Heart Institute, Wynnewood

19104

University of Pennsylvania, Philadelphia

21201

University of Maryland, Baltimore

22908

University of Virginia Health System, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

27599

University of North Carolina - Chapel Hill, Chapel Hill

28203

Carolinas Medical Center, Charlotte

30308

Emory University, Atlanta

30309

Piedmont Heart Institute, Atlanta

32545

Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Bad Oeynhausen

32605

The Cardiac & Vascular Institute Research Foundation, Gainesville

33462

Florida Heart & Vascular Care - JFK, Atlantis

34102

NCH Heart Institute, Naples

37205

Saint Thomas Health, Nashville

37232

Vanderbilt University Medical Center, Nashville

44195

Cleveland Clinic, Cleveland

45219

The Christ Hospital, Cincinnati

46290

St. Vincent Heart Center of Indiana, Indianapolis

48109

University of Michigan Hospital and Health Systems, Ann Arbor

48202

Henry Ford Health System, Detroit

50937

Herzzentrum der Uniklinik Köln, Cologne

53105

Herzzentrum Universitätsklinik Bonn, Bonn

55131

Johannes Gutenberg-Universität Mainz, Mainz

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

64111

Saint Luke's Hospital of Kansas City, Kansas City

66160

Kansas University Medical Center, Kansas City

67214

Ascension Via Christi St. Francis, Wichita

74104

Oklahoma Heart Institute, Tulsa

75093

Baylor Heart Hopsital Plano, Plano

77004

HCA Houston Healthcare, Houston

77030

The University of Texas Health Science Center at Houston, Houston

80538

Medical Center of the Rockies, Loveland

81377

Klinikum der Universität München - Großhadern, München

84107

Intermountain Medical Center, Murray

85013

SJHMC Heart and Vascular Institute, Phoenix

85712

Tucson Medical Center, Tucson

90048

Cedars-Sinai Medical Center, Los Angeles

92037

Scripps Memorial Hospital La Jolla, La Jolla

94118

Kaiser Permanente San Francisco, San Francisco

94143

University of California San Francisco, San Francisco

94305

Stanford University, Stanford

95817

UC Davis Medical Center, Sacramento

97293

Oregon Health & Science University, Portland

98101

Virginia Mason Franciscan Health, Seattle

98122

Swedish Medical Center, Seattle

98195

University of Washington, Seattle

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07960

Morristown Medical Center, Morristown

08903

Rutgers Robert Wood Johnson Medical School, New Brunswick

01307

Herzzentrum Dresden Universitätsklinik, Dresden

04289

Herzzentrum Leipzig GmbH, Leipzig

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY